Complementary-material element for an ostomy appliance

ABSTRACT

A complementary-material element configured to be attachable to a base plate of an ostomy appliance and comprising a release layer, the element comprising a release layer comprises a neutralizing component configured to be releasable from the complementary-material element in response to subjection of the complementary-material element to moisture. The complementary-material element comprises a first surface and a second surface, wherein the first surface is provided with a first cover layer.

The invention relates to a complementary-material element for an ostomyappliance and a kit of parts.

SUMMARY

The present disclosure provides aspects of a complementary-materialelement configured to be attachable to a base plate of an ostomyappliance. The complementary-material element is defined andcharacterized by the appended claims.

BACKGROUND

Stomal output often contains body fluids and visceral contents that areaggressive to both the skin of a user and to ostomy devices, inparticular these have a detrimental effect on the efficiency andintegrity of the adhesive materials that are applied to attach theostomy device to the user's skin surface. Some ostomists may choose orhave to wear their device for prolonged periods of time. For users ingeneral, and particularly for these ostomists safe, reliable andefficient ostomy devices are highly desirable. Furthermore, a devicethat protects the skin of the user against the aggressive contents ofthe stomal output is desired.

Numerous attempts have been made to provide ostomy devices to meet thesuch demands, e.g. the demand of prolonged wear time and/or higher skinprotection, but the provision of sufficient efficiency to achieve asatisfactory long wear time of ostomy devices or skin protectioncontinues to be an unmet need. Ostomists (ostomy appliance users) andhealth care professionals alike would welcome improvements in ostomydevices to better meet such demands.

BRIEF DESCRIPTION OF THE DRAWING

The accompanying drawings are included to provide a furtherunderstanding of embodiments and are incorporated into and a part ofthis specification. The drawings illustrate embodiments and togetherwith the description serve to explain principles of embodiments. Otherembodiments and many of the intended advantages of embodiments will bereadily appreciated as they become better understood by reference to thefollowing detailed description. The elements of the drawings are notnecessarily to scale relative to each other. Like reference numeralsdesignate corresponding similar parts.

FIG. 1 is a schematic, cross-sectional view of one embodiment of a bodyside member of an ostomy appliance.

FIG. 2 is a top view of an embodiment of a complementary-materialelement.

FIG. 3 is a schematic cross-sectional perspective view of an embodimentof a complementary-material element.

FIG. 4 is a schematic cross-sectional view of an embodiment of acomplementary-material element with sealed edges.

FIG. 5 is a schematic cross-sectional view of an embodiment of acomplementary-material element with a tab member.

FIG. 6 is a schematic cross-sectional perspective view of an embodimentof a complementary-material element with a foam layer.

FIG. 7 is a top view of an embodiment of a complementary-materialelement with a cut-out section.

FIG. 8 is a cross-sectional view of an embodiment of an appliance with acomplementary-material element extending over the inner proximal wall ofthe collecting bag.

FIG. 9 is a cross-sectional view of an embodiment of an appliance with aasymmetric complementary-material element extending further upwards.

FIG. 10 is a cross-sectional view of an embodiment of an appliance witha asymmetric complementary-material element extending further downwards.

FIG. 11 is a cross-sectional view of an embodiment of an appliance witha complementary-material element where the element is attached inpoints.

DETAILED DESCRIPTION

In the following Detailed Description, reference is made to theaccompanying drawings, which form a part hereof, and in which is shownby way of illustration specific embodiments in which the invention maybe practiced. In this regard, directional terminology, such as “top”,“bottom”, “front”, “back”, “leading”, “trailing” etc., is used withreference to the orientation of the Figure(s) being described. Becausecomponents of embodiments can be positioned in a number of differentorientations, the directional terminology is used for purposes ofillustration and is in no way limiting. It is to be understood thatother embodiments may be utilized, and structural or logical changes maybe made without departing from the scope of the present invention. Thefollowing detailed description, therefore, is not to be taken in alimiting sense, and the scope of the present invention is defined by theappended claims.

It is to be understood that the features of the various exemplaryembodiments described herein may be combined with each other, unlessspecifically noted otherwise.

Throughout this disclosure, the words “stoma” and “ostomy” are used todenote a surgically created opening bypassing the intestines or urinarytract system of a person. The words are used interchangeably, and nodifferentiated meaning is intended. The same applies for any words orphrases derived from these, e.g. “stomal”, “ostomies” etc. Also, thesolid and liquid wastes emanating from the stoma may be referred to asboth stomal “output,” “waste(s),” and “fluids” interchangeably.

By (stomal) output is herein meant the effluent from a stoma, beingfeces and/or urine in a more or less viscous form and/or mucins secretedfrom the epithelial layer of the alimentary canal. In the case of acolostomy, the output may be quite solid, whereas an ileostomy mayproduce more liquid output. The output may contain digestive fluids withenzymes and other components that may be aggressive to the skin and thusmay cause maceration and contact dermatitis of the skin if brought intocontact with it as well as the output may comprise components that mayattack and degrade the adhesive.

A subject having undergone ostomy surgery may be referred to as“ostomist” or “ostomate”—moreover, also as “patient” or “user”. However,in some cases “user” may also relate or refer to a health careprofessional (HCP), such as a surgeon or an ostomy care nurse or others.In those cases, it will either be explicitly stated, or be implicit fromthe context that the “user” is not the “patient” him- or herself.

In the following, whenever referring to proximal side of a device orpart of a device, the referral is to the skin-facing side, when theostomy appliance is worn by a user. Likewise, whenever referring to thedistal side of a device or part of a device, the referral is to the sidefacing away from the skin, when the ostomy appliance is worn by a user.In other words, the proximal side is the side closest to the user, whenthe appliance is fitted on a user and the distal side is the oppositeside—the side furthest away from the user in use.

The axial direction is defined as the direction of the stoma, when theappliance is worn by a user. Thus, the axial direction is generallyperpendicular to the skin or abdominal surface of the user.

The radial direction is defined as transverse to the axial directionthat is transversely to the direction of the stoma. In some sentences,the words “inner” and “outer” may be used. These qualifiers shouldgenerally be perceived with reference to the radial direction, such thata reference to an “outer” element means that the element is farther awayfrom a centre portion of the ostomy appliance than an element referencedas “inner”. In addition, “innermost” should be interpreted as theportion of a component forming a centre of the component and/or beingadjacent to the centre of the component. In analogy, “outermost” shouldbe interpreted as a portion of a component forming an outer edge orouter contour of a component and/or being adjacent to that outer edge orouter contour.

The use of the phrase “substantially” as a qualifier to certain featuresor effects in this disclosure is intended to simply mean that anydeviations are within tolerances that would normally be expected by theskilled person in the relevant field.

In one aspect, the present disclosure relates to acomplementary-material element configured to be attachable to a baseplate of an ostomy appliance and comprising a release layer, wherein therelease layer comprises a neutralizing component configured to bereleasable from the complementary-material element in response tosubjection of the complementary-material element to moisture, whereinthe complementary-material element comprises a first surface and asecond surface, wherein the first surface is provided with a first coverlayer.

The complementary-material element (in the following designated ‘CME’)is to be understood as an element which is separate from and attachableto a base plate of an ostomy appliance. The wording ‘base plate’ iscommonly used within the technical field of ostomy appliances and theskilled person is familiar with this term. The term ‘base plate’ is usedfor that element or part of an ostomy appliance which attaches theappliance to a skin surface around a user's stoma, most commonly by anadhesive interface. Thus, it is the intention of the terminology ‘CME’used in this disclosure to mean an element which is not a base plate ofan ostomy appliance, but which itself is a ‘stand-alone’ element. The‘CME’ is configured to be attached to a base plate of an ostomyappliance, but is otherwise an individual, or distinct, element.

Particularly, the release layer of the ‘CME’ includes a neutralizingcomponent. The neutralizing component is configured to be released fromthe ‘CME’ in response to subjection of the ‘CME’ to moisture. Thus, whenthe ‘CME’ is attached to (used with) a base plate of an ostomy appliancebeing worn by a user, the moisture content of the stomal output will actto initiate, sustain and/or accelerate release of the neutralizingcomponent from the ‘CME’. Suitable materials for the neutralizingcomponent are discussed below.

When an ostomy appliance is applied to the skin surrounding a stoma,adhesive on the base plate ideally provides a tight fit or sealing tothe skin, to avoid stomal output from propagating under the adhesive ofthe base plate, which is potentially damaging to the skin and prone todegrading the adhesive as explained above. Any stomal output propagatingor seeping under the adhesive of base plate is to be avoided as best aspossible as such output can lead to maceration of the skin, contactdermatitis and degradation of the adhesive, potentially resulting inadhesive failure and eventually leakage of the stomal output onto theuser's clothes, presenting a stigmatising embarrassment and clearlydiscomfort to the user. However, experience has shown that avoiding anyor all kind of such problems is extremely difficult and that usersregularly are faced with these issues.

According the disclosure, such adhesive failures can be overcome in thatthe neutralizing composition included in the release layer of the ‘CME’is configured to be released in the presence of moisture and thereby actto neutralize the aggressive contents of the stomal output to help avoidor reduce maceration of the skin, contact dermatitis and/or degradationof the adhesive. Additionally, and/or alternatively, the neutralizingcomposition acts to slow or decelerate the damaging effects of thestomal output, in some cases providing for increased or prolonged weartime of the ostomy appliance, which in turn provides both practical andeconomic advantages.

When preparing a base plate of an ostomy appliance to fit an individualuser's stoma and body (skin surface), it often involves trimming orcutting (e.g. with special scissors) into correct shape and size anostomy receiving opening in the base plate of the appliance. To avoidthe thereby cut edge from gnawing on the stoma, and since adaptation ofsuch opening in the base plate is difficult to make with a great deal ofprecision, the cutting/adaptation almost always leaves a small gap(distance) between an edge of the cut opening in the adhesive base plateand the user's stoma, when the appliance is applied around the stoma ofthe user. However, such gap does help to provide room for the stoma to‘work’ (i.e. expand and contract), caused inter alia by peristalticmovements of the intestine; often, the stoma enlarges when deliveringstomal output and shortens when not. This gap is also called theperistomal gap. Stomal output inevitably flows into the peristomal gapand will over time be able to propagate under the adhesive interfacebetween the skin and the base plate.

Consequently, provision of an ostomy receiving opening and/or theperistomal gap also contributes to the risk of damage and degradation ofthe adhesive layer of the base plate followed potentially by skinirritation, maceration and/or other skin problems.

By providing a ‘CME’ including a release layer comprising a neutralizingcomponent together with a base plate for an ostomy appliance, theneutralizing component can be directed into contact with the stomaloutput and into the peristomal gap. Both the user's skin and theadhesive layer on the base plate at, and adjacent to the peristomal gap,will thereby be protected from the damaging effects of the stomaloutput. While a small amount of neutralizing component may be forcedinto the collecting bag as stomal output leaves the stoma and passesthrough the stoma-receiving opening and into the collecting bag, the‘CME’ of this disclosure is configured to ensure that a major portion ofthe neutralizing component is directed to flow particularly into theperistomal gap to interact with stomal output to neutralize its harmfulcomponents and avoid or delay degradation of the adhesive layer.

Experience shows that stomal output is able to flow substantiallycontinuously or enter the collecting bag in bursts when exiting thestoma, depending among other factors on the type of stoma. If a user ofan ostomy appliance is in an upright position, stomal output may flowcontinuously downwards due to gravity and thereby act to primarily ‘wet’or ‘soil’ a portion of the base plate located below (beneath or under)the stoma when the appliance is worn. However, stomal output is known toalso creep upwards to ‘wet’ or ‘soil’ a portion of the base platelocated above (higher or over) the stoma when the appliance is worn.

Particularly, when stomal output enters the inside of a collecting bagin bursts, with a distal wall of the collecting bag pressed close to thestoma (e.g. due to the user's clothing, belt, trouser lining etc.), thestomal output is known to be able to spread all over a central portionof the base plate, including also the area above (higher/over) thestoma. For a user wearing a collecting bag with his/her clothes pushingthe collecting bag's distal wall against the stoma, stomal output can betrapped in and fill a volume defined by the base plate, the distal wallof the collecting bag and an attachment between the base plate and thecollecting bag (potentially a coupling arrangement between the baseplate and the collecting bag). Thus, stomal output may not immediatelyor exclusively be forced downwards by gravity but can also be affected(by force(s) acting on it) to ‘wet’ or ‘soil’ an area of the collectingbag above (over) an inlet opening in the collecting bag and possiblyalso ‘soil’ the peristomal gap.

In conclusion, during normal use of an ostomy appliance, stomal outputdoes not subject itself to an ‘idealistic behaviour’ of simply beingforced by gravity to the ‘bottom’ of the collecting bag's reservoirvolume. Instead, stomal output can (or be forced to) travel in anydirection from the inlet opening of the collecting bag, including toareas/locations above (higher/over) the stoma. In some cases, stomaloutput can even be smeared against the walls (distal and/or proximal) ofthe collecting bag and further onto anywhere on a distal surface of thebase plate and ‘back’ into the peristomal gap. Consequently, it is noteasy to foresee where stomal output will ‘end up’ and present a problem.The present disclosure provides solutions which help avoid or preventadhesive failure or at least reduce the impact of the stomal output'spotentially damaging and detrimental effects on the user's skin surface,stoma and/or on the components of the ostomy appliance by offering a‘CME’ which is configured to release a ‘mitigating’ neutralizingcomponent.

From the above, it is understood that in conceiving the invention of thepresent disclosure, the inventors realized that the neutralizingcomponent must not per se be provided close to, or in direct contactwith, the stoma's surface, or directly onto the peristomal gap or skinsurface for the neutralizing component to be able to provide itsbeneficial effects. Indeed, it was realized that the neutralizingcomponent's effects are achievable inter alia by allowing theneutralizing component to be released in the peristomal gap, into anarea of the collecting bag around the bag's inlet opening and/or on thebase plate, such as on a central portion of the base plate, including ona distal surface of the base plate facing away from the skin of theuser, when the ostomy appliance is worn. In some implementations, the‘CME’ can be adapted to release the neutralizing component towards botha proximal surface of the base plate (facing the user's skin) and adistal surface of the base plate (facing or being exposed to the insideof the collecting volume of the collecting bag).

In embodiments, the ‘CME’ comprises an opening which is configured toreceive the stoma and/or the stomal output from the user. Inembodiments, the opening may be smaller or correspond to thethrough-going hole of the base plate. The size of the hole in the baseplate and the opening of the ‘CME’ may be adapted by cutting prior toapplication to fit the stoma. In embodiments, the opening may be largeror correspond to the through-going hole of the base plate. Inembodiments, the hole in the base plate may be cut larger prior toapplication and if the opening in the ‘CME’ is larger, cutting in the‘CME’ may be unnecessary.

In embodiments, the ‘CME’ is sealed along the inner edge, being the edgesurrounding the opening. Such sealing may prevent the content of the‘CME’ to flow and escape the ‘CME’ during storage. In embodiments, the‘CME’ comprises means for breaking the sealing along the opening, so theneutralizing component can be released during use. In embodiments, thesealing comprises a label or string, that when removed from the ‘CME’,tears the sealed edge open.

In embodiments, the ‘CME’ is open along the inner edge, therebyproviding a ready-to-use product.

The ‘CME’ is provided with a cover layer on the first surface of theelement. In embodiments, the first surface is on the distal side of the‘CME’. The cover layer facilitates that the ‘CME’ does not stick to theinside of the collecting bag as well as the cover layer may be able tocontrol the release of the neutralizing component.

In embodiments, the second surface complementary-material element isprovided with a second cover layer. In embodiments, the second surfaceis on the proximal side of the ‘CME’. In embodiments, the first and thesecond cover layer are sealed together along an outer periphery todefine a closed envelope containing the release layer. In embodiments,the sealing along the outer edge is not entirely fluid tight but enablespockets of gas inside the envelope to escape during the sealing process.

In embodiments, the second surface of the complementary-material elementis configured to be attached to a base plate of an ostomy appliance. Thesurface may comprise an adhesive material. The adhesive material may forexample be a continuous adhesive layer, a pattern-coated adhesive layeror the adhesive material may be arranged in one or more discrete areas.In embodiments, the adhesive material is arranged in concentric circlesaround a hole for accommodating a stoma. In embodiments, a plurality ofindividual adhesive areas is provided on an external surface of the‘CME’. In embodiments, the complementary-material element furthercomprises at least one release liner. The release liner may cover theadhesive material and is removed before use.

In embodiments, the first cover layer is water impermeable or has a lowpermeability to water. This facilitates that the release layer will notunintended leak through the first cover layer from the ‘CME’. I case therelease layer is viscous or comprises volatile components, animpermeable cover layer provides better storage stability. Inembodiments, the first cover may comprise a polymer film such as apolyurethane film, a polyethylene film, a PVDC (polyvinyl dichloride)film or laminates comprising these.

In embodiments, the first cover layer is water permeable. This allowsthe moisture from the output from the stoma to enter the release layerover a larger surface thereby achieving a faster release of theneutralizing component. In embodiments, the cover layer is designed toprovide a controlled release of the neutralizing component. Inembodiments, the first cover layer may be a non-woven or a net. Inembodiments, the first cover layer is an impermeable film provided witha plurality of holes.

In embodiments, the second cover layer is water impermeable or has a lowpermeability to water. In embodiments, the second cover may comprise apolymer film such as a polyurethane film, a polyethylene film, a PVDC(polyvinyl dichloride) film or laminates comprising these.

In embodiments, the second cover layer is water permeable. Inembodiments, the cover layer may be a non-woven or a net. Inembodiments, the second cover layer is an impermeable film provided witha plurality of holes.

In embodiments, the first cover layer and the second cover layer aremade from the same material.

In embodiments, the cover layer is transparent, translucent or opaque,enabling that the content of neutralizing component can be inspectedfrom the outside. In embodiments, the cover layer is non-transparent inorder to visually conceal any output from the stoma entering theenvelope.

In embodiments, at least one surface of the ‘CME’ is embossed to show apattern. In embodiments, the embossment is provided by attaching thefirst and the second layer together in a pattern of lines or points.

In embodiments, a foam layer is inserted between the release layer andthe first cover layer. Such foam layer may be wetted by the output andthereby exposing the release layer to the moisture from the output overthe first surface of the ‘CME’.

The complementary-material element may have any suitable shape. Inembodiments, the element is disc shaped, optionally with a centralthrough-going hole for accommodating the stoma. In embodiments, the‘CME’ is provided without a hole, so the user can adapt the hole to hisor her stoma. In embodiments, it has a substantially flat, sheet-likeconfiguration. In embodiments, the complementary-material element has anouter periphery being circular, oval or droplet shaped.

In embodiments, the complementary-material element is provided with acut-out section extending radially inwards from an edge of the element.Such cut-out section facilitates easy placement of the element aroundthe stoma.

In embodiments, the release layer is provided as a matrix structure. Inembodiments, the release layer can include more than one neutralizingcomponent. In embodiments, a neutralizing component can include morethan one kind of neutralizing component (e.g. directed towardsneutralizing different substances of the stomal output). In someimplementations, the helpful effect(s) presented by one neutralizingcomponent and/or one neutralizing component can be amplified by thepresence of another kind of neutralizing component and/or neutralizingcomponent to provide even better results in terms of preventing or atleast reducing the prevalence of adhesive failures, skin maceration,contact dermatitis, leakage incidents etc.

In embodiments, a matrix structure of the release layer comprises aneutralizing component incorporated therein. The neutralizing componentcan be dissolved in the matrix or it can be dispersed as particles inthe matrix. In embodiments, the matrix comprises coated neutralizingsubstance particles. The matrix serves as a carrier of the neutralizingcomponent and is configured to release the neutralizing component. Inembodiments, the matrix is configured to release the neutralizingcomponent when the matrix is subjected or exposed to certain conditions.Such conditions may for example be in the presence of stomal outputcontaining moisture or in the presence of moisture from other sources,e.g. sweat from the user's body.

Inside the collecting volume of a collecting bag, humidity will quicklyreach close to 100% humidity, so the presence of moisture issubstantial. In embodiments, the release of neutralizing componentinitiates shortly after applying the ostomy appliance on the user, dueto the high relative humidity in the collecting bag.

In embodiments, the matrix comprises one or more of a gel, foam, filmlayer or paper or a coating. Such coating may for example be solid orpowder coating. In embodiments, the matrix and the neutralizingcomponent form a colloidal solution such as a sol. One suitable exampleof a matrix comprises an adhesive comprising 50% w/w polyisobutylene(PIB) and 25% w/w CMC and 25% w/w pectin.

In embodiments, a matrix in the form of a water-soluble film comprises aPVOH based thermoplastic film, such as a Monosol® 7031 film from kurakayWS Film Division™, Portage, Ind., United States.

In embodiments, the matrix is configured to be soluble in water(moisture) or a component of the stomal output. It can be slowlysoluble, by slowly is herein meant that the matrix will not degradeinstantly, but slowly dissolve during wear of the base plate. Inembodiments, when output from the stoma is floating over the releaselayer, the matrix will dissolve, and the neutralizing component will bewashed away, and at least a part of the neutralizing component willenter into the peristomal gap.

In embodiments, the matrix is configured to absorb moisture and turninto a gel like material when wetted by moisture uptake. The gel can bedelivered in an initial dry form and configured to subsequently swellinto a gel when brought into contact with moisture. The gel can beslowly soluble in water or in a component of the output (moisture) or itcan be insoluble, but able to release the neutralizing component whenexposed to the stomal output and/or moisture. Examples of suitablematerials for the matrix may be polyethylene glycol (PEG), polyvinylalcohol (PVA), polyvinyl pyrrolidone (PVP), ethylene vinyl acetate (EVA)based matrix and hydrocolloids such as CMC or gelatine.

In embodiments, the matrix comprises polysaccharides and/orhydrocolloids. The polysaccharides or hydrocolloids can be configured todissolve or hydrate when exposed to output, thereby releasing theneutralizing component.

In embodiments, the matrix comprises protein.

In embodiments, the matrix is substantially non-adhesive. Bynon-adhesive is to be understood that the matrix is not adhesive (doesnot stick). In some implementations, however, the matrix is configuredto, under certain circumstances, become slightly sticky when wetted. Anon-adhesive matrix will be less prone to sticking to the distal wall ofthe bag. In embodiments, the matrix may be sticky, but the presence of afirst cover layer may prevent the matrix to stick to the distal wall ofthe bag.

In one aspect, the disclosure relates to a kit of parts comprising acomplementary-material element as disclosed herein and a base plate foran ostomy appliance. The base plate comprises an adhesive layer providedon a first surface of a backing layer. Optionally, the base platecomprises a release liner provided on the adhesive first surface of thebacking layer.

In embodiments, a body waste collecting bag attached to the secondsurface of the backing layer of the base plate.

In embodiments, at least a portion of the element extends radially tocover at part of an inner proximal wall of a collecting bag. Thisfacilitate a larger area of release layer as well as the thickness ofthe ‘CME’ can be reduced, thereby enhancing the flexibility of theappliance.

In embodiments, a first coupling half provided on the second surface ofthe backing layer of the base plate and a body waste collecting baghaving a second coupling half provided around an inlet opening of thecollecting bag.

In embodiments, the base plate comprises second attachment means forattachment to the complementary-material element.

In embodiments, the complementary-material element is/are attachable tothe base plate by a user or a health care professional. Alternatively,the element is attached to the base plate at manufacture and deliveredto the user in an attached configuration. Such attachment inter aliaallows for easier adaptation of a stoma-receiving opening in the baseplate when customization of the size and shape of the opening to theuser's stoma is required. In embodiments, the ‘CME’ is attached to thebase plate by welding, lamination, hot melt adhesive or double facedadhesive tape.

In embodiments, the kit of parts further comprises a body wastecollecting bag attached to the second surface of the backing layer ofthe base plate. In these embodiments, the collecting bag is alreadyattached to the base plate at manufacture and may be understood as aone-piece ostomy appliance, as is commonly understood in the ostomyappliance area. Such embodiments of a one-piece ostomy appliance of thedisclosure provide one-piece appliances which may have prolonged weartime, due to the combination with the attached or attachablecomplementary-material element. The collecting bag can thus bedetachably or permanently attachable to the base plate via a couplingarrangement.

In embodiments, a first coupling half is provided on the second surfaceof the backing layer of the base plate. The body waste collecting bagincludes a second coupling half provided around an inlet opening of thecollecting bag. This provides for the complementary-material element ofthe disclosure to also be used with and improve the life- or wear timealso of a two-piece ostomy appliance, also commonly understood in thearea.

In embodiments, the base plate comprises second attachment means forattachment to the complementary-material element. In these embodiments,the element comprises first attachment means to engage or attach to thesecond attachment means of the base plate.

In embodiments, the complementary-material element is configured as aring-shaped element or as a disc-shaped element. Thereby, the ‘CME’ isintuitive and easily handled by the user or health care professional.This is particularly, but not exclusively, advantageous when the ‘CME’is combined with and attached to a base plate of an ostomy appliance bythe user or health care professional (i.e. it is not attached to thebase plate at manufacture) before the base plate is being applied to theskin of the user.

In embodiments, the ‘CME’ comprises an opening which is configured toreceive the stoma and/or the stomal output from the user. In someimplementations, the ‘CME’ is a ring-shaped element comprising a centralopening, wherein attachment of the ‘CME’ to the base plate becomesparticularly intuitive, because the ring-shaped element (the ‘CME’) isconfigured to align with a stoma-receiving opening in the base plate andto be customized to fit well with the size and shape of an individualstoma.

In embodiments, the collecting bag comprises a second half of a couplinginterface that is configured to couple with a first half of the couplinginterface on the base plate to attach the stomal collecting bag to thebase plate.

In embodiments, a distal surface of the base plate includes a first halfof a coupling interface for coupling the base plate to a collecting bag.In one embodiment, the coupling half is a flange adapted to provide asurface for attaching another coupling half in the form of an adhesiveflange provided on the collecting bag. In embodiments, the first half ofthe coupling interface is configured as a flexible, planar annularflange optionally comprising an adhesive. The first coupling half isadapted to couple with a second coupling half provided around an inletopening of the collecting bag by means of an adhesive. The adhesivecoupling may provide a releasable or a permanent adhesive couplingengagement between the components.

In embodiments, the coupling half is an annular ring comprising anupstanding flange protruding from the distal surface perpendicularthereto for attaching another coupling half in the form of a couplingring provided on the collecting bag. In one embodiment, a first couplinghalf is attached to a distal surface of the base plate. In embodiments,the first coupling half is attached to the distal surface by an adhesiveor by welding, but other ways of attaching are acceptable. Other typesof suitable coupling arrangements are widely available within the ostomycare field.

By neutralizing component is herein meant a neutralizing substancecapable of neutralizing or at least minimizing the level of skin- oradhesive-aggressiveness of stomal output.

In embodiments, the neutralizing component comprises a clay, such asorganophilic clay, for example bentonite or synthetic clay such aslaponite. Examples of such clays are disclosed in EP 1 140 009.

In embodiments, the neutralizing component comprises potato-derivedinhibitors or protease inhibitors. Examples of potato-derived inhibitorssuch as potato protein are disclosed in EP 1 736 136.

In embodiments, the neutralizing component can include an adhesive. Inother embodiments, the neutralizing component comprises a powder. Inother embodiments, the neutralizing component comprises a liquid. Inother embodiments, the neutralizing component comprises a gel. In otherembodiments, the neutralizing component comprises a plurality ofpellets. In yet other embodiments, the neutralizing component comprisesa combination of any one or more of an adhesive, a powder, a liquid, agel and/or a plurality of pellets. These options each provides one ormore different advantages such as including, but not limited to,manipulability, shelf life, suitability for different kinds of stomaloutput (colostomy output tends to be much more solid than ileo- andurostomy output), processing characteristics during manufacture andothers. By selectively applying these options, individually or incombination, to meet particular requirements of a target ostomy/ostomistgroup, the suitability of the ostomy appliance and the improvement inreduction or elimination of the problems discussed above, includingreducing the risk of leakage, can be significantly improved.

Particularly, in embodiments wherein the neutralizing componentcomprises an adhesive, suitable materials include adhesives, such as,but not limited to, adhesive pastes. Suitable materials for a paste-typeadhesive comprise adhesives of the types disclosed in WO2010/069334.Other types of adhesive pastes are also acceptable.

DETAILED DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic cross-sectional side view of one embodiment of anostomy appliance 10 including a complementary-material element 60, abase plate 20 to which the complementary-material element 60 isattached, and a stomal output collecting bag 50 coupled to the baseplate at location 100 and configured to collect stomal output coming outof the user's stoma 110. The base plate 20 is adhesively attached to theskin surface S surrounding the stoma 110. Also visible is an area orzone immediately surrounding the stoma 110, the area or zone designatedthe peristomal gap 120. The embodiment of FIG. 1 further illustrates afirst cover layer 80 located on a first surface 130 of thecomplementary-material element 60. On a second surface of thecomplementary-material element is provided a second cover layer 140. Thesecond cover layer 140 is attached to the central portion of the backinglayer 40 of the base plate 20.

FIG. 2 is a schematic view, seen from above, of an embodiment of acomplementary-element 60. The complementary-material element is hershown as symmetric disc shaped, but may come in other shapes, forexample as a disc with a cut-out 150 as shown in FIG. 7. In FIG. 7 isshown the cut-out 150 facilitates easy placement around a stoma. Inembodiments, the complementary-material element may have an asymmetricalshape. The complementary-material element may be provided with athrough-going hole for accommodating a stoma.

FIG. 3 show a cross-sectional perspective view of acomplementary-material element 60, cut along the A-A line shown in FIG.2. The complementary-material element 60 comprises a neutralizingcomponent matrix 70. On a first surface 130 of thecomplementary-material element is provided a first cover layer and on asecond surface 140 of the complementary-material element is provided asecond cover layer 90. The first cover layer 80 and the second coverlayer 90 are sealed along an outer periphery 160 of thecomplementary-material element to produce a closed envelope containingthe neutralizing component matrix 70. The second cover layer 90 may beprovided with an adhesive material (not shown) for attachment to a baseplate.

In FIG. 4 is shown a cross-sectional view of a complementary-materialelement 60 wrapped in a first cover layer 80 and a second cover layer 90sealed along the outer periphery 160. At the centre portion 170, theneutralizing component matrix 70 is absent or substantially absent,leaving the first cover 80 and the second cover layer 90 next to eachother's or solely separated by a neglectible amount of neutralizingcomponent matrix 70. Before use, a through-going hole is cut in thecentre portion to adapt the complementary-material element 60 to fitaround a stoma. In FIG. 5 is shown a cross-sectional perspective view ofan embodiment where an outer edge portion of the first cover layer 80and/or the second cover layer 90 is elongated radially into a tabportion 180, thereby facilitating easy removal of thecomplementary-material element 60 when the tab portion 180 is pulledaway from the base plate.

In FIG. 6 is shown a cross-sectional perspective view of an embodimentcomprising a neutralizing component matrix 70, the neutralizingcomponent matrix 70 being provided with a foam layer 200 insertedbetween the first surface 130 of the neutralizing component matrix 70and the first cover layer 80. The foam layer 200 facilitatesdistribution of output from the stoma to reach the entire first surface80 of the release layer 70, thereby providing faster release ofneutralizing component from the neutralizing component matrix 70. Thefirst cover layer 80 may prevent the complementary-material element 60from sticking to the collecting bag 50. The second surface 140 of thecomplementary-material element 60 is provided with an adhesive material210 for attaching the complementary-material element 60 to a base plate.

FIG. 8 shows a cross-sectional view of an embodiment of an appliancewith a complementary-material element 60 attached. Thecomplementary-material element extends radially from the through-goinghole 190 to an outer edge portion. The complementary-material elementextends over the central portion of the base plate 20 and further overthe location 100 for attachment of the collecting bag 50 to cover aportion of the inside proximal wall 230 of the collecting bag 50. Thecomplementary-material element may be attached to the inside proximalwall or it may only be attached to the base plate. The attachment to thebase plate may be over a continuous area or it may be in discrete pointsor lines. In embodiments, the complementary-material element may beattached by welding, lamination or adhesive.

FIGS. 9 and 10 show embodiments of appliances with an asymmetricalcomplementary-material element attached to the base plate. In FIG. 9,the complementary-material element 60 extend further towards the top ofthe collecting bag than it extends towards the bottom of the collectingbag. The extended portion 220 may be attached to the distal inner wall240 of the collecting bag 50. In FIG. 10, the complementary-materialelement 60 extends further towards the bottom of the collecting bag thanit does towards the top of the collecting bag. The extended part 220 maybe unattached to the inner proximal wall 230 of the collecting bag 50.

In FIG. 11, the complementary-material element 60 is attached to thebase plate 20 in discrete points 210. This construction facilitates moreflexibility of the combined base plate and complementary-materialelement when the base plate is bended during application and use.

Although specific embodiments have been illustrated and describedherein, it will be appreciated by those of ordinary skill in the artthat a variety of alternate and/or equivalent implementations may besubstituted for the specific embodiments shown and described withoutdeparting from the scope of the present invention. This application isintended to cover any adaptations or variations of body side members forostomy appliances as discussed herein. Therefore, it is intended thatthis invention be limited only by the claims and the equivalentsthereof.

1.-17. (canceled)
 18. An ostomy appliance comprising: a base plateattachable to skin of a user around a stoma; and acomplementary-material element comprising a first surface having a firstcover layer and a second surface attachable to the base plate, where thecomplementary-material element comprises a release layer between thefirst surface and the second surface; wherein the release layercomprises a neutralizing component configured to be released from thecomplementary-material element in response to moisture contact.
 19. Theostomy appliance of claim 18, wherein the complementary-material elementis provided with an opening adapted to receive the stoma, and thecomplementary-material element is sealed around a periphery of theopening to prevent release of the neutralizing component.
 20. The ostomyappliance of claim 19, wherein the complementary-material element issealed around a periphery of the opening by one of a removable label anda string, where each of the label and the string is adapted to beremoved to expose the neutralizing component at the periphery of theopening.
 21. The ostomy appliance of claim 18, wherein the secondsurface is provided with a second cover layer.
 22. The ostomy applianceof claim 21, wherein the first cover layer and the second cover layerare sealed together along an outer periphery of the first cover layerand the second cover layer to prevent release of the neutralizingcomponent.
 23. The ostomy appliance of claim 18, wherein thecomplementary-material element is provided with an opening adapted toreceive the stoma, and the opening is uncovered to allow release of theneutralizing component.
 24. The ostomy appliance of claim 18, whereinthe first cover layer is water impermeable.
 25. The ostomy appliance ofclaim 18, wherein the first cover layer is water permeable.
 26. Theostomy appliance of claim 18, wherein the first cover layer istransparent and adapted to allow a user to visually inspect theneutralizing component.
 27. The ostomy appliance of claim 18, whereinthe release layer comprises a matrix structure containing theneutralizing component.
 28. The ostomy appliance of claim 18, whereinthe second surface comprises an adhesive material.
 29. The ostomyappliance of claim 18, further comprising: a foam layer inserted betweenthe release layer and the first cover layer.